It's been a rough ride for Anthera Pharmaceuticals Inc. (ANTH: Quote) ever since it halted a late-stage heart drug trial in March, following recommendation by the independent Data Safety Monitoring Board, and the shares are down 69 percent year-to-date at $1.95. Now, as the company gets ready to report final top-line data from a mid-stage clinical trial of lupus drug Blisibimod this quarter, it is worth keeping an eye on this stock for the coming weeks.
For readers who are new to Anthera, here is a brief overview of the upcoming event...
Anthera's product candidate Blisibimod, also known as A-623, is in a phase IIb study, dubbed PEARL-SC. The study, which was initiated in 2010, completed enrollment of the targeted number of 540 lupus patients last October.
The therapeutic benefit of weekly and monthly subcutaneous injections of Blisibimod in lupus patients is being examined in the study. The primary endpoint of the study is clinical improvement at 24 weeks in the systemic lupus erythematosus responder index, a recently recognized FDA endpoint for demonstrating clinical efficacy.
Early data from the PEARL-SC study, announced last December, indicated that weekly and monthly subcutaneous doses of Blisibimod resulted in statistically significant reductions of B-cells, which correlates to reduction in disease activity. Elevations in B-cells have been associated with an increased risk of disease activity in lupus patients.
Final results from the PEARL-SC clinical study are expected this quarter. (2Q, 2012).
Lupus is a chronic autoimmune disease in which the body's immune system attacks its own cells and tissues, damaging the organs. The disease affects various body parts, including joints, skin, blood and kidneys.
It is estimated that about 1.5 million Americans and 5 million people worldwide have a form of lupus.
Human Genome Sciences Inc.'s (HGSI: Quote) and GlaxoSmithKline plc's (GSK) Benlysta, approved by the FDA in 2011, is the first treatment to be developed for lupus in over 50 years.
A couple of compounds are being tested as a potential treatment of lupus, and they include, Atacicept, being developed by Bristol-Myers Squibb Co. (BMY) and Merck Serono S.A., which is in a phase III clinical study; Epratuzumab, being developed by Immunomedics Inc. and UCB S.A., which has just entered a phase III study and LY2127399, being developed by Eli Lilly, which is also in phase III studies.
A quick look at Anthera's balance sheet...
Since inception in September 9, 2004 through March 31, 2012, the company had accumulated a deficit of $221.9 million and has never generated any revenue.
The company ended the first quarter of 2012 with roughly $44.0 million in cash and cash equivalents and short-term investments. Cash burn for the second quarter ending June 30, 2012 is expected to be about $13 million to $15.0 million.
Anthera went public in March 2010, offering its shares at a price of $7.00 each. The stock has thus far hit a 52-week low of $1.44 and a 52-week high of $8.89. ANTH closed Friday's trading at $1.95, down 2.01%.
Given that Anthera has a key catalyst to watch out for, will investors warm up to this stock? Stay tuned...
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by RTT Staff Writer
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